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Course Overview
To place your pharmaceutical, biotech of advanced therapy on the US market you must first gain FDA regulatory approval. Like all regulatory agencies, the FDA process requires skill and knowledge to navigate efficiently and to ensure fast approval.
This FDA regulatory training course examines the processes, terminology and best practices to ensure your interactions with the FDA are positive. Once completed, you will have the confidence to successfully submit Investigational New Drug Applications (IND) and New Drug Applications (NDA). You will learn the practical regulatory skills to get your pharmaceutical or biotech approved by FDA reviewers. You will also learn how best to gain approval for generics and biosimilars.
The course begins at the time stated at the top of the page
The course is broken up into modules outlined below
There will be breaks between modules
Session 1
27 April 2023 | 180 mins | 9:30 AM UK
Overview of the US Food and Drug Administration (FDA)
Brief history of the FDA and Regulations and how we got to where we are today
Review the FDA’s organisation by division
Examining the drug development regulations in the US
The drug development process in the US
Clinical trials and Investigational New Drug (INDs)
Discover who is involved in development and the types of INDs
Basic understanding of the IND content and timings
Defining the regulatory requirements for submitting an IND
FDA Meetings
Review the various FDA meetings (Type A, B and C)
Discuss meetings on Biosimilars
Office of Tissues and Advanced Therapies (OTAT) meetings
Session 2
27 April 2023 | 180 mins | 1:30 PM UK
Evaluation of FDA review options
Understanding the following FDA review options:
Fast track / Priority review / Accelerated review / Breakthrough status
OTAT and RMAT Process / Interact
Reviewing the NDA process /BLA Process
Defining full NDAs / BLA
Examining the NDA categories
Explaining abbreviated NDAs and 505 (b) (2)
Learn the requirements and processes for biologics and advanced therapies (Cell and Gene)
ANDA (Generics) and 351K (Biosimilars)
Review of key differences to EU
Overview of regulatory positions
US strategies for development
Additional Considerations
Change Control
Use of Agents
Master Files
OTC Monographs
Andrew Willis is a regulatory and Development consultant with 30 years of experience. Andrew’s management roles have seen him act as global Vice President of Regulatory Affairs and Medical Affairs, creating business for complex pharmaceutical development projects. Andrew has gained therapeutic experience in areas covering CNS, oncology, urology and pain management.
Experienced with both EU and US applications (NDA, 505 B 2, ANDA, BLA, MAA) for NCEs, generics and line extensions, with particular knowledge of sterile and biotech products. Andrew’s experience covers multiple applications, scientific advice meetings and orphan drug applications. He has significant experience with novel drug delivery systems has been utilized in all the above type of applications.
Andrew continues to provide training for all major companies and also a number of EU Member states agencies in CMC, variations and advanced regulatory affairs. He currently delivers extensive training courses on the EU and US, specifically looking at QbD, CMC regs and lifecycle management. Andrew has delivered multiple courses on FDA regulatory affairs, supporting professionals with their FDA submissions. He has delivered FDA regulatory courses on a range of products such as pharmaceuticals, biotech, cell and gene, generics and biosimilars.
This course is aimed at professionals who work in regulatory affairs and are involved in the approval of therapeutics in the US. These include: Regulatory Affairs Professionals | CMC Regulatory Professionals | Product Registration Personnel | Project Managers in Regulatory Affairs | Compliance Managers | Documentation Specialists | Quality Professionals and QPs.
Could your team benefit from this course?
We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.
For more information you can email us at [email protected] or call +44 (0) 203 111 7357.
Complete our contact form by following the link. Get in touch.
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• This course is delivered online
• For live online courses, module durations are approximate
• You will have full access to the training portal and the recordings for 2 weeks after the training
